Gene expression profile testing of cancer tissue

Policy context

There are a growing number of gene expression profile tests for cancer tissue designed to inform treatment decisions after diagnosis. Potential benefits of these types of tests include more appropriate treatment decisions and better patient outcomes, including avoiding treatment-related side effects and the potential cost savings from forgoing unnecessary treatments. This topic was selected for a health technology assessment because of medium concerns for the safety of these tests, medium/high concerns for efficacy, and high concerns for cost.

Status: Decision completed

Primary Criteria Ranking

  • Safety = Medium
  • Efficacy = Medium/High
  • Cost = High

Assessment timeline

  • Draft key questions published: October 6, 2017
  • Public comment period: October 6 to 20, 2017
  • Final key questions published: November 28, 2017
  • Draft report published: January 4, 2018
  • Public comment period: January 4 to February 2, 2018
  • Final report published: February 21, 2018
  • HTCC public meeting: March 16, 2018


The lifetime risk of developing cancer is about 40 percent, and one in every five Americans will die from cancer.1 Strategies for reducing the burden of cancer include preventing the disease, early diagnosis of cancer, and appropriate treatments of diagnosed cancers.2 Common treatments for cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and immunotherapy.3 The most appropriate treatments for a particular cancer can depend on the cancer's severity (e.g., cancer stage and grade), the patient's age and health status, response to previous treatments, and other factors.

In recent years, gene expression profile testing of cancer tissue has been used to help inform decisions on the most appropriate treatments for a cancer. Gene expression profile testing identifies the genes in a cancer cell or tissue that are making messenger RNA, which carry the genetic information needed by the cancer cells to make proteins. Some gene expression profile tests are designed to increase the accuracy of the prognosis for a cancer patient. If a test predicts that a cancer is slow growing or is unlikely to metastasize, then active surveillance of the cancer could be the most appropriate course. If a test predicts that a cancer is at high risk for progression and metastasis, then more aggressive treatments could be warranted.4


  1. American Cancer Society. Lifetime risk of developing or dying from cancer. 2016;
  2. Centers for Disease Control and Prevention. Cancer. 2016;
  3. National Cancer Institute. Types of cancer treatment. 2017;
  4. Meleth S, Reeder-Hayes K, Ashok M, et al. Technology assessment of molecular pathology testing for the estimation of prognosis for common cancers. In: Technology Assessment of Molecular Pathology Testing for the Estimation of Prognosis for Common Cancers. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014.